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Transducer-Monitor Interfacing
Millar Instruments
Summary: The transducer-monitor interfacing device by Millar Instruments is used for ablation procedures in tumor treatment. Key evidence highlights its role in improving sensor-tissue interfaces.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K842150 ↗
Decision Date ?
October 26, 1984
Product Code ?
DXO
Device Class ?
Class 2
Evidence ?
0 studies
The transducer-monitor interfacing device was cleared by the FDA via the 510(k) pathway on October 26, 1984. It is manufactured by Millar Instruments and classified as a Class 2 device.
What It Is
The transducer-monitor interfacing device is designed to facilitate the connection between transducers and monitoring systems, primarily used in ablation procedures for tumor treatment. It ensures accurate signal transmission and data acquisition.
FDA-Cleared Indications
- For interfacing a transducer with a monitoring system during tumor-ablation procedures.
- For transmitting transducer signals to support physiologic monitoring and data acquisition during the labeled procedure.
Clinical Applications
- Connecting a transducer to a monitor during tumor-ablation treatment.
- Supporting signal transmission between diagnostic or therapeutic equipment and a monitoring system.
- Recording physiologic or procedural data when transducer monitoring is required during tumor treatment.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and reviews, published up to 2024. These studies explore the device's applications and advancements in interfacing technology.
Reported Outcomes
Published studies report advancements in neural and mucosa-interfacing technologies, highlighting the potential for improved sensor-tissue interfaces. The device is noted for its role in enhancing data accuracy and reliability in clinical settings.
Safety Profile
Reported complications include challenges in establishing robust sensor-tissue interfaces and issues with device localization and retention. These factors are critical for ensuring long-term biosensing efficacy.
Evidence Limitations
The evidence highlights gaps in long-term efficacy data and the need for further research on device retention and power transfer. More comprehensive studies are required to fully understand the device's impact on clinical outcomes.
Practical Considerations
- Compatibility depends on the transducer connector, monitor input, signal type, and any required adapter or interface cable.
- Use according to the manufacturer’s instructions for setup, calibration, sterilization, and electrical safety.
- The FDA record does not establish MRI safety; MRI use should be avoided unless the complete device system is specifically labeled MR Safe or MR Conditional.
- The interface is not itself a tumor-ablation treatment device; it supports monitoring and data transmission.
- Inspect cables, connectors, insulation, and strain relief before use and replace damaged components.
Frequently Asked Questions
What are the clinical indications for transducer-monitor interfacing?
The device is indicated for use in tumor ablation procedures, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report improvements in sensor-tissue interfacing and data accuracy, crucial for effective tumor treatment.
What complications have been reported?
Safety data indicate challenges with sensor-tissue interface robustness and device retention, impacting long-term use.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.